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Related Manuals for Steeper Myo Kinisi
Summary of Contents for Steeper Myo Kinisi
- Page 1 Myo Kinisi Distributeur Technical Manual...
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Page 3: Table Of Contents
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Contents Box Contents ..........................Features of the Myo Kinisi ..................... Steeper Myo Kinisi ........................The Steeper Configuration Device ..................Important Clinician Information ..................Important User Information ....................Technical Information ......................Environmental and Operational Conditions .............. -
Page 4: Box Contents
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Box Contents Myo Kinisi with PVC hand shell Technical Manual (for clinician use) User Guide (please supply to the end user) Myo Kinisi Technical Manual... -
Page 5: Features Of The Myo Kinisi
Independently operated mechanical safety feature. Durable PVC hand shell. Programmed using the Steeper Configuration Device, which enables the choice between Mode 0-4 for the Myo Kinisi (see the Steeper Configuration Device - Programming Guide for Myo Kinisi). Myo Kinisi Technical Manual... -
Page 6: Steeper Myo Kinisi
Kinisi is used alongside the Steeper S-Charge System and Steeper Electrodes. A PVC hand shell encloses the inner mechanism to protect the Myo Kinisi and provide a hand shape. Prior to providing the user with the Myo Kinisi, a Steeper cosmetic glove must be fitted to protect the hand shell. -
Page 7: The Steeper Configuration Device
The Steeper Configuration Device The Steeper Configuration Device offers prosthetists the choice between five modes to suit patient needs. The Myo Kinisi is supplied in Mode 1: ‘Dual Elec’ the parameters of this mode can be adjusted using the Steeper Configuration Device. -
Page 8: Important Clinician Information
This Device is a Class I Medical Device which meets the general safety and performance requirements in MDR 2017/745 Annex I. Do not adjust, dismantle, attempt to maintain or modify the Myo Kinisi or its associated components. It is important the user inspects their myoelectric hand regularly to ensure early detection of any problems. - Page 9 To clean the outer glove or the hand shell, use a damp cloth to gently remove any marks. Do not use solvents. Do not expose the Myo Kinisi to a naked flame or excessive heat. Avoid exposing the hand to long periods of direct sunlight.
- Page 10 A User Guide will be supplied with the hand for their reference. This product is intended for use by a single user during daily activities. See warranty terms for further information. If this product does not meet your expectations, please contact Steeper Customer Services or your local Steeper distributor. www.steepergroup.com for the latest version of this Technical Manual.
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Page 11: Important User Information
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Important User Information If your Myo Kinisi has been fitted with a Quick Disconnect Wrist, the device must be consciously positioned when performing any turning actions to prevent unintentional disconnection of the hand atthe wrist. - Page 12 The maximum carry load for the Myo Kinisi is 12.5kg (27.55lb). Before detaching the Myo Kinisi from the prosthesis, you must ensure that the Myo Kinisi is switched off, press and hold the function button; as described in ‘Location of the Function Button’ (p.14) and then check the hand functionality to ensure it is switched off.
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Page 13: Technical Information
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Technical Information Hand sizes*: 7¼” 7¾” 8¼” Maximum opening width 100mm (3.9”) 100mm (3.9”) 100mm (3.9”) Maximum length - 170mm (6.7”) 170mm (6.7”) 175mm (6.89”) fingertip to hand base Maximum speed when... -
Page 14: Environmental And Operational Conditions
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Environmental and Operational Conditions Storage and Transport -20°C (-4°F) to +50°C (+122°F) If the hand has been in storage or has been transported, place the device in an ambient temperature (20°C) two hours prior to using. -
Page 15: The Function Button
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. The Function Button The Myo Kinisi has a low profile function button, located on the back of the hand (as shown in the diagram). The Myo Kinisi is on by default after connecting to a power source; initial start ... - Page 16 The force required to press this button has been designed to avoid accidental Note: operation. If the Myo Kinisi is not functioning this will likely be because the system is off - Note: press the button firmly to turn it on.
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Page 17: Specific Activity Use
- particularly if associated muscle contractions in the residual limb will occur. The function button is used to power the hand off. If the Myo Kinisi has been fitted with a Quick Disconnect Wrist, the device must be consciously positioned when performing any turning actions to prevent unintentional disconnection of the hand at the wrist. -
Page 18: Activating The Auto-Grip Feature
When gripping an object, this feature will offer a grip strength that automatically adjusts to accommodate for any slip of the gripped object. Prosthetists can enable/disable this feature using the Steeper Configuration Device. Auto-grip utilises the function button; please see page 14 for a diagram of location. -
Page 19: Mechanical Safety Release
The patient must be confident in how to safely manoeuvre the safety release back into its correct position. A video guide can be found on the Steeper website www. steepergroup.com. Caution: This must only be used in the event of loss of power on the ... - Page 20 Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Mechanical Safety Release Re-engaging the safety release: To reset the mechanical safety release, push the button and move the thumb back to its original position, you will then feel it relocate. To check if the thumb has re-engaged ask the user to close the hand - if the thumb moves accordingly, it has been reset correctly.
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Page 21: Additional Safety Feature
When the battery runs low the hand will slow; this is intentional to signal the user to recharge or change their battery. If the battery fully discharges during use, as a final action, the Myo Kinisi will open and remain in an open position until the battery is recharged or changed. -
Page 22: Maximum Pulses
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Maximum Pulses The grip can be maximised by maintaining or pulsing the close signal after gripping an object. A number of pulses will be felt as the grip increases. This feature incrementally increases grip to the pre-set ‘maximum pulse count’ (1-3). When the ‘maximum pulse count’... -
Page 23: Myo Kinisi Control Parameters
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Myo Kinisi Control Parameters The Myo Kinisi hand offers five mode options. Each mode provides a different variety of characteristics allowing mode selection based on the need of the user. These modes cannot be selected or adjusted without the use of the Steeper Configuration Device. -
Page 24: Adjustable Parameters Table
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Adjustable Parameters Table The adjustment parameters available for use with each of the five Myo Kinisi hand modes are illustrated in the table below: Electrode Input 1 Input 2 Control Parameters Mode... -
Page 25: Myo Kinisi Mode Overview
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Myo Kinisi Mode Overview 17.1 Mode 0: ‘AUTO CLOSE’ Single Site: Auto Close A signal rising above the ‘ON Level’ threshold will open the hand. When the signal drops below the ‘ON Level’ the hand will close, regardless of the speed at which it is removed. -
Page 26: 17.3 Mode 2: 'Quick Open
For more information about the mode options for the Myo Kinisi please refer to the Steeper Configuration Device Programming Guide, which can be found at: www. -
Page 27: Removing The Hand Shell
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Removing the Hand Shell Remove the retaining ring from the wrist of the inner hand shell. Open the hand slightly and isolate the power supply. With the hand firmly and carefully secured in a vertical position, begin to firmly ... -
Page 28: Fitting The Hand Shell
Fitting the Hand Shell If the hand shell requires fitting, the instructions below must be followed: Steeper recommend securing the hand firmly and carefully in a vertical position, with the hand in a slightly open position and the power supply isolated. -
Page 29: Fitting Replacement Palps
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Fitting Replacement Palps If the palps require replacement due to damage to the hand, please follow the instructions below. If you require any assistance with this process, please contact the Steeper Customer Services team, or your local distributor. -
Page 30: Donning The Cosmetic Glove
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Donning the Cosmetic Glove The Elegance Plus glove is designed to be used with the Myo Kinisi, however, a number of alternative gloves may also be applied. For the best results, please see the instructions supplied with the glove you are fitting. -
Page 31: Doffing The Cosmetic Glove
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Doffing the Cosmetic Glove The suggested method to remove the cosmetic outer glove is to slightly open the hand and isolate the power supply. Apply a water-based surgical lubricant to the outer glove surface, before ... -
Page 32: Warranty Terms
The company, therefore, reserves the right to introduce changes and withdraw products without notice. The service life of the Myo Kinisi is five years. Outside of this, please contact your local Steeper representaive for possibilities regarding service or repair. -
Page 33: Returns
Steeper distributor to request a RTA - Returns Authorisation Number and 8.2.1 FRM 028 Product Concern Report Form. All items must be returned to Steeper with an RTA and completed 8.2.1 FRM 028 Product Concern Report with the product return. The RTA number must be clearly stated on the outside of the packaging prior to return. -
Page 34: Quality Assurance
Steeper is registered with both the Medicines and Healthcare Regulatory Authority in the UK, and the Food and Drugs Administration of the United States Government for the manufacture and supply of prosthetic and orthotic products. -
Page 35: Test Certification
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Test Certification The Device and its associated components listed within this document have been tested and certified to the following standard and requirements: IEC 60601-1:2005, AMD:2012 IEC 60601-1-11:2015 IEC 60601-1-2:2014 RTCA DO – 160G Includes meeting requirements of ISO 14971:2019. -
Page 36: Disposal
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Disposal The Myo Kinisi is an electrical device and should not be mixed with general household waste. For proper treatment, recovery and recycling, please take this product(s) to designated collection points. Disposing of this product correctly will help save valuable resources... -
Page 37: Symbols Used On Product & Packaging
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Symbols Used on Product & Packaging Symbol Definition Source Indicates the medical device ISO 15223- 1:2016 manufacturer. Reference no. 5.1.1. (ISO 7000-3082) Indicates the authorised representative ISO 15223-1:2016 in the European Community / European Reference no 5.1.2... - Page 38 Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Symbols Used on Product & Packaging Symbol Definition Source Indicates the medical device may be ISO/DIS 15223- 1:2020(E) used multiple times (multiple Reference no. 5.4.12. procedures) on a single patient. (ISO 7000-3706)
- Page 39 Myo Kinisi van Steeper, distributeur Loth Fabenim B.V. Myo Kinisi Technical Manual...
- Page 40 Authorized representative for Manufacture EU countries Steeper Group Emergo Europe Unit 3 Stourton Link, Intermezzo Drive Prinsessegracht 20 Leeds, LS10 1DF, United Kingdom 2514 AP The Hague Tel: +44 (0) 870 240 4133 The Netherlands Email: customerservices@steepergroup.com Tel: +31 70 345 8570 Email: EmergoEurope@ul.com...
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